NCT03426514

Brief Summary

This study is designed to evaluate the short-term and long-term results after three-port laparoscopic surgery for colorectal cancer（TLSC） compared with conventional laparoscopic surgery for colorectal cancer（CLSC）.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

January 31, 2018

Last Update Submit

February 12, 2020

Conditions

Colorectal Cancer

Keywords

Colorectal cancerLaparoscopic surgeryThree-port

Outcome Measures

Primary Outcomes (1)

  • Early morbidity rate

    morbidity rate 30 days after surgery

    30 days after surgery

Secondary Outcomes (10)

  • Operative time

    intraoperative

  • Intraoperative blood loss

    intraoperative

  • Lymph node detection

    14 days after surgery

  • Proximal resection margin

    14 days after surgery

  • Distal resection margin

    14 days after surgery

  • +5 more secondary outcomes

Study Arms (2)

Three-port Laparoscopic Surgery

EXPERIMENTAL

Patients with colorectal cancer undergo three-port laparoscopic surgery.

Procedure: Three-port Laparoscopic Surgery

Conventional Laparoscopic Surgery

EXPERIMENTAL

Patients with colorectal cancer undergo conventional laparoscopic surgery（4 or more ports）.

Procedure: Conventional Laparoscopic Surgery

Interventions

Three-port Laparoscopic SurgeryPROCEDURE

Patients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery.

Three-port Laparoscopic Surgery
Conventional Laparoscopic SurgeryPROCEDURE

Patients undergo conventional laparoscopic surgery（4 or more ports）.The surgery will be routinely completed by a surgeon，a camera-person and another assistant to provide counter-traction.

Conventional Laparoscopic Surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index (BMI) \<30 kg/m2
  • Tumor located in colon and high rectum (the lower border of the tumor is above the peritoneal reflection)
  • Pathological colorectal carcinoma
  • Clinically diagnosed cT1-4aN0-2 M0 lesions according to the 7th Edition of AJCC Cancer Staging Manual with or without neoadjuvant therapeutic history
  • ECOG score is 0-1
  • ASA score is Ⅰ-Ⅲ
  • Informed consent

You may not qualify if:

  • Previous gastrointestinal surgery
  • History of inflammatory bowel disease
  • History of familial adenomatous polyposis（FAP）
  • Pregnant woman or lactating woman
  • Severe mental disease
  • Intolerance of surgery for severe comorbidities
  • Emergency operation due to complication (bleeding, perforation or obstruction) caused by colorectal cancer
  • Requirement of simultaneous surgery for other disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Related Publications (2)

  • Tawfik Amin A, Elsaba TM, Amira G. Three ports laparoscopic resection for colorectal cancer: a step on refining of reduced port surgery. ISRN Surg. 2014 Mar 12;2014:781549. doi: 10.1155/2014/781549. eCollection 2014.

    PMID: 25006515BACKGROUND

  • Seow-En I, Tan KY, Mohd Daud MA, Seow-Choen F. Traditional laparoscopic colorectal resections can be performed effectively using a three-port technique. Tech Coloproctol. 2011 Mar;15(1):91-3. doi: 10.1007/s10151-010-0660-6. Epub 2011 Jan 14. No abstract available.

    PMID: 21234638BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Tao Zhang, MD

    Ruijin Hospital

    STUDY CHAIR

Central Study Contacts

Ren Zhao, MD

CONTACT

+86-18917762018rjzhaoren@139.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physicion

Study Record Dates

First Submitted

January 31, 2018

First Posted

February 8, 2018

Study Start

March 25, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2025

Last Updated

February 13, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)